Non-alcoholic Fatty Liver DiseaseNCT05054712
Prevalence of Metabolic Liver Diseases in Patients With Type 1 Diabetes Mellitus
An observational study of Non-alcoholic Fatty Liver Disease and Glycogen Hepatopathy, run by Consorci Sanitari de l'Alt Penedès i Garraf at 2 sites in Spain.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) has been extensively studied in the context of type 2 diabetes mellitus (T2D) due to its higher prevalence and its association with obesity and syndrome metabolic, a well-established risk factor for NAFLD. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Glycogen Hepatopathy, Type 1 Diabetes
- How many people
- 250 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Sep 2021to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Descriptive observational study of prevalence (cross-sectional) in patients with T1D of the healthcare area of the Hospital del Mar and Hospital de Vilafranca (Barcelona).
Who may be able to join
- Men and women aged ≥ 18 years.
- Diagnosed with T1D of at least 6 months of evolution.
- Patients who give their informed consent in writing.
Who cannot join
- Active alcoholism> 30 g / day in men and> 20 g / day in women.
- Known non-metabolic liver disease: alcoholic hepatitis, viral hepatitis from HBV infection and / or HCV, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, autoimmune hepatitis, hepatic granulomatous (tuberculosis, mycobacteria, histoplasmosis), hepatic lymphoma, primary neoplasia liver, liver metastasis.
- Active treatment with hepatotoxic drugs: amiodarone, isoniazid, rifampicin, sulfa drugs, tetracyclines, amoxycline / clavulanate, ketoconazole, methotrexate, valproic acid, trazodone, tamoxifen, methyldopa, reverse transcriptase inhibitors, chemotherapy, immunotherapy.
- Pregnant women.
- Acute decompensation of T1D (ketoacidosis) in the 3 months prior to inclusion. The inclusion after this period.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
Silvia Ballesta, + 34 932 48 30 00 ext. 3902, SBallesta@psmar.cat
- Recruiting
Hospital Comarcal de l'Alt Penedès
Vilafranca del Penedès, Barcelona, 08720
Silvia Ballesta, 9381810440 ext. 1027, sballesta@csap.cat
About this study
Official title: Prevalence of Metabolic Liver Diseases in Patients With Type 1 Diabetes Mellitus: Non-alcoholic Fatty Liver Disease and Glycogenic Hepatopathy
Nonalcoholic fatty liver disease (NAFLD) has been extensively studied in the context of type 2 diabetes mellitus (T2D) due to its higher prevalence and its association with obesity and syndrome metabolic, a well-established risk factor for NAFLD. Although several studies have reported the accumulation of liver fat in patients with type 1 diabetes mellitus (T1D), the prevalence, etiology, and the consequences of NAFLD in patients with T1D are poorly characterized, requiring more studies in this field. In addition, liver involvement at the metabolic level in patients with T1D raises the differential diagnosis between NAFLD and glycogen hepatopathy (GH), a rare complication associated with the poorly metabolic control of diabetes and probably underdiagnosed, since the ultrasound pattern is the same than the NAFLD. The investigators have designed a cross-sectional observational study with the objective of describing the prevalence of metabolic liver diseases (NAFLD and GH) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca, as well as studying the relationship of these pathologies with the degree of metabolic control, the presence of metabolic syndrome and the presence of micro and macrovascular complications.
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 1, Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the prevalence of metabolic liver diseases (NAFLD and GH) by different diagnostic approaches in the population of patients with T1D.
To describe the prevalence of metabolic liver diseases (NAFLD and GH) by different diagnostic approaches (levels of transaminases, liver ultrasound, liver MRI and, in selected cases, liver biopsy) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca.
Measured: 2 years
Secondary outcomes (3)
To study the relationship between metabolic liver diseases in patients with T1D and the degree of metabolic control of diabetes.
Measured: 2 years
To study the relationship between metabolic liver diseases in patients with T1D and the presence of metabolic syndrome.
Measured: 2 years
To study the relationship between metabolic liver diseases in patients with T1D and the presence of microvascular and macrovascular complications.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054712
- Sponsor's protocol ID
- 21-E5
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Metabolic Liver Diseases in Patients With Type 1 Diabetes Mellitus: Non-alcoholic Fatty Liver Disease and Glycogenic Hepatopathy
- ClinicalTrials.gov ID
- NCT05054712
- Acronym / sponsor ID
- 21-E5
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nonalcoholic fatty liver disease (NAFLD) has been extensively studied in the context of type 2 diabetes mellitus (T2D) due to its higher prevalence and its association with obesity and syndrome metabolic, a well-established risk factor for NAFLD. Although several studies have reported the accumulation of liver fat in patients with type 1 diabetes mellitus (T1D), the prevalence, etiology, and the consequences of NAFLD in patients with T1D are poorly characterized, requiring more studies in this field. In addition, liver involvement at the metabolic level in patients with T1D raises the differential diagnosis between NAFLD and glycogen hepatopathy (GH), a rare complication associated with the poorly metabolic control of diabetes and probably underdiagnosed, since the ultrasound pattern is the same than the NAFLD. The investigators have designed a cross-sectional observational study with the objective of describing the prevalence of metabolic liver diseases (NAFLD and GH) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca, as well as studying the relationship of these pathologies with the degree of metabolic control, the presence of metabolic syndrome and the presence of micro and macrovascular complications.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Descriptive observational study of prevalence (cross-sectional) in patients with T1D of the healthcare area of the Hospital del Mar and Hospital de Vilafranca (Barcelona).
Key inclusion criteria (3 listed)
- Men and women aged ≥ 18 years.
- Diagnosed with T1D of at least 6 months of evolution.
- Patients who give their informed consent in writing.
Key exclusion criteria (5 listed)
- Active alcoholism> 30 g / day in men and> 20 g / day in women.
- Known non-metabolic liver disease: alcoholic hepatitis, viral hepatitis from HBV infection and / or HCV, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, autoimmune hepatitis, hepatic granulomatous (tuberculosis, mycobacteria, histoplasmosis), hepatic lymphoma, primary neoplasia liver, liver metastasis.
- Active treatment with hepatotoxic drugs: amiodarone, isoniazid, rifampicin, sulfa drugs, tetracyclines, amoxycline / clavulanate, ketoconazole, methotrexate, valproic acid, trazodone, tamoxifen, methyldopa, reverse transcriptase inhibitors, chemotherapy, immunotherapy.
- Pregnant women.
- Acute decompensation of T1D (ketoacidosis) in the 3 months prior to inclusion. The inclusion after this period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the prevalence of metabolic liver diseases (NAFLD and GH) by different diagnostic approaches in the population of patients with T1D.
Time frame: 2 years
To describe the prevalence of metabolic liver diseases (NAFLD and GH) by different diagnostic approaches (levels of transaminases, liver ultrasound, liver MRI and, in selected cases, liver biopsy) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca.
3 secondary outcomes
To study the relationship between metabolic liver diseases in patients with T1D and the degree of metabolic control of diabetes.
Time frame: 2 years
To study the relationship between metabolic liver diseases in patients with T1D and the presence of metabolic syndrome.
Time frame: 2 years
To study the relationship between metabolic liver diseases in patients with T1D and the presence of microvascular and macrovascular complications.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hospital Comarcal de l'Alt Penedès
Vilafranca del Penedès, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease and Glycogen Hepatopathy, run by Consorci Sanitari de l'Alt Penedès i Garraf at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the prevalence of metabolic liver diseases (NAFLD and GH) by different diagnostic approaches in the population of patients with T1D. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.